Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT05236218
Status:
UNKNOWN
Last Update Posted:
2023-03-08
First Post:
2022-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
To Better Understand the Most Important Factors for Patients When They Decide on the Type of Treatment They Receive for Muscle Invasive Bladder Cancer (MIBC).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017060', 'term': 'Patient Satisfaction'}, {'id': 'D057240', 'term': 'Patient Preference'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C022673', 'term': 'delta 24-sterol reductase'}, {'id': 'D010865', 'term': 'Pilot Projects'}], 'ancestors': [{'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005069', 'term': 'Evaluation Studies as Topic'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-07', 'studyFirstSubmitDate': '2022-02-02', 'studyFirstSubmitQcDate': '2022-02-02', 'lastUpdatePostDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Willingness to accept treatment attributes, and trade-offs between these, using a study-specific Discrete Choice Experiment (DCE) Questionnaire', 'timeFrame': 'Through study completion, an average of 1 year (Discrete Choice Experiment (DCE) Questionnaire). Trade-off from Marginal Rate of Substitution calculate as percentage points (0 to 100). ]'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Muscle invasive bladder cancer', 'Patient Preference'], 'conditions': ['Muscle Invasive Bladder Cancer', 'Surgery', 'Sexual Wellbeing', 'Patient Satisfaction', 'Patient Preference']}, 'descriptionModule': {'briefSummary': 'Through our study, we aim to understand the most important factors for patients when they decide on the type of treatment they receive for MIBC. Our study consists of a discrete choice experiment (DCE): a type of questionnaire used to elicit preferences in the absence of data. DCEs are frequently used in oncological research to elicit preferences from participants without directly asking them to state their preferred options. Participants undertaking our DCE questionnaire will presented with a series of alternative hypothetical scenarios containing several variables or "attributes" (5), each of which may have a number of variations or "levels".', 'detailedDescription': 'The study will be conducted using validated and established protocols for undertaking DCEs. A literature review was undertaken to assess what the most important considerations where for patients when making decisions about the treatment they receive for MIBC. Using this literature search as a starting point, discussion groups with relevant healthcare professionals and service users were undertaken to decide on the final attribute and levels for the questions. Five attributes were selected through an iterative process - Body image, Life expectancy, Side-effects from treatment, Living as bladder cancer survivor, and Sexual wellbeing\n\nThe study is divided into three stages:\n\n1. Interviews with experienced healthcare professionals and service users to finalise attributes and levels to be used for the questionnaire\n2. A representative sample of patients (\\~10) will be asked to complete the questionnaire in addition to a brief unstructured interview to assess understanding (e.g. readability and ease of completing the questionnaire)\n3. Necessary changes based on feedback from the pilot study will be applied before the main study is carried out'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men or women with diagnosed MIBC who are currently undergoing treatment or have previously completed treatment for MIBC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with MIBC cancer and currently undergoing treatment or have previously completed treatment for MIBC\n\nExclusion Criteria:\n\n* Any of other type of bladder cancer (unknown, metastatic, or non muscle invasive bladder cancer)'}, 'identificationModule': {'nctId': 'NCT05236218', 'briefTitle': 'To Better Understand the Most Important Factors for Patients When They Decide on the Type of Treatment They Receive for Muscle Invasive Bladder Cancer (MIBC).', 'organization': {'class': 'OTHER', 'fullName': "King's College London"}, 'officialTitle': "Patients' Treatment Preferences For Muscle Invasive Bladder Cancer Cancer: A Discrete Choice Experiment", 'orgStudyIdInfo': {'id': 'PTPDCE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pilot study (n = 10)', 'description': '10 participants will be recruited to complete the questionnaire (version 1). A research assistant will be present to help support them /answer any questions around the format. Readability and comprehension will be noted. Any changes (if needed) can be implemented to its format before the main data collection.', 'interventionNames': ['Other: Semi-Structured Interview Patients Interview']}, {'label': 'Discrete Choice Experiment Questionnaire (n = 50)', 'description': 'Discrete Choice Experiment (DCE) Patients', 'interventionNames': ['Other: Discrete Choice Experiment (DCE) Patients DCE Questionnaire']}], 'interventions': [{'name': 'Discrete Choice Experiment (DCE) Patients DCE Questionnaire', 'type': 'OTHER', 'description': 'Discrete Choice Experiment (DCE) Patients', 'armGroupLabels': ['Discrete Choice Experiment Questionnaire (n = 50)']}, {'name': 'Semi-Structured Interview Patients Interview', 'type': 'OTHER', 'otherNames': ['Pilot study'], 'description': 'First version of questionnaire (readability/comprehension check)', 'armGroupLabels': ['Pilot study (n = 10)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Liam Mannion', 'role': 'CONTACT', 'email': 'liam.mannion@kcl.ac.uk'}], 'facility': "Guy's and St Thomas' NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Simon Hughes, MD', 'role': 'CONTACT', 'email': 'Simon.1.hughes@kcl.ac.uk', 'phone': '+44 20 7188 3761'}, {'name': 'Liam Mannion', 'role': 'CONTACT', 'email': 'Liam.mannion@kcl.ac.uk', 'phone': '+44 20 7140 5685'}], 'overallOfficials': [{'name': 'Simon Hughes', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KCL/GSTTH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College London", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}